The application process for RZN certification of Class I medical devices typically takes about 3 to 6 months. The process includes several review stages:

1. Document Submission:

   • Preparation: Gather and prepare all required documentation.
   • Submission: Submit your application and documentation to Roszdravnadzor.

2. Initial Review:

   • Document Assessment: Roszdravnadzor conducts a preliminary review of the submitted documents to ensure completeness and correctness.
   • Additional Information: If needed, Roszdravnadzor may request additional information or clarifications.

3. Technical Evaluation:

   • Technical Assessment: The technical details of your device are evaluated to ensure compliance with Russian standards and regulations.
   • Possible Testing: Depending on the device, there may be a need for product testing.

4. Inspection (if applicable):

   • On-Site Inspection: Roszdravnadzor may perform an on-site inspection of your manufacturing facilities if required.

5. Certification Decision:

   • Final Review: Roszdravnadzor completes the final review of all submitted materials and results.
   • Certification Issuance: If all requirements are met, Roszdravnadzor issues the certification for your Class I medical device.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn